RecruitingNAINTERVENTIONAL

Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

This study is exploring how a robotic walking machine, called Trexo, might help people with conditions like cerebral palsy or other physical disabilities improve their walking. We know these machines can be helpful, but we don't fully understand why or how to get the most out of them. We'll be looking at how different settings on the Trexo impact things like how much you move, how you walk, your brain activity, muscle stiffness (spasticity), and tiredness. The aim is to find out the best ways to use this kind of robot to help with rehabilitation and give ideas for how to make the Trexo even better. This is an early study to learn more.

At a glance

Status

Recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

14 Mar 2022

Estimated completion

01 Dec 2026

Physical Disability CP (Cerebral Palsy)Developmental Disability

What is this study about?

This study is about a special robotic walking device called the Trexo. It's designed to help people who have difficulty walking because of conditions like cerebral palsy or other issues that affect their muscles or nerves. While we've seen that these robot-assisted walking machines can be really useful, we don't fully understand *how* they help or the best ways to use them to get the most benefit.

Our main goal is to look closely at what happens during a single session using the Trexo. We'll be trying out different settings on the machine. For example, in one setting, the robot might do most of the work to move your legs for you (we call this "endurance mode"). In another setting, the robot might give less help, encouraging you to use more of your own strength (we call this "strength mode"). We might also try adjusting how you're supported in the machine, like whether you use a special seat or not.

By exploring these different settings, we want to see how they impact various things. This includes how much physical activity you get, how your walking changes, what happens with your brain activity, whether it helps with muscle stiffness (spasticity), and if it affects how tired you feel. Ultimately, we hope to learn how this type of robot-assisted walking helps with rehabilitation, makes up for difficulties, and how we might improve or change the Trexo for even better results in the future. This is an early stage study to gather more information.

Key takeaways

This study explores how a robotic walking machine, Trexo, can help people with walking difficulties.
It aims to find the best ways to use the Trexo by trying different settings.
We'll look at how these settings affect walking, physical activity, brain activity, and tiredness.
It doesn't involve any medication; it's all about using the robotic device.
Participation involves a fitting session and two main testing sessions.
Your involvement helps us understand how to improve robot-assisted therapy for others.

Who may be eligible?

To be able to take part in this study, you need to have difficulty walking because of a condition that affects your brain, nerves, or muscles. You also need to be able to fit safely into the Trexo robotic walking machine.

This means you should weigh less than 150 pounds (about 10 stone 10 pounds) and be shorter than 5 feet 7 inches (about 170 cm).

However, you cannot join if you weigh more than 150 pounds, are taller than 5 feet 6 inches, or if your doctor has told you not to put weight through your legs for medical reasons (for example, if you've recently had an operation on your bones or joints).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have difficulty walking due to a nerve or muscle condition?
Do I weigh less than 150 pounds (about 10 stone 10 pounds)?
Am I shorter than 5 feet 7 inches (about 170 cm)?
Has my doctor said it's okay for me to put weight on my legs?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey will start with a "familiarisation and fitting" session. In this session, a member of the study team will help you get comfortably and safely fitted into the Trexo machine. This is also your chance to try it out and get used to how it feels.

After this, there will be two main testing sessions. In these sessions, we'll try different settings on the Trexo, such as the "endurance" mode (where the robot helps more) or the "strength" mode (where you do more work). We might also test different ways of supporting you in the machine. Each testing session will involve looking at things like your physical activity, walking patterns, and possibly brain activity or how tired you feel.

While only three visits (one fitting and two testing sessions) are required, you and your family can choose to have more testing sessions if you want to explore other aspects of the training – for example, if the first two sessions focused on walking, you could come back to look at brain activity. The total time for each visit and the overall duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study might benefit you by giving you the chance to try a robotic walking machine that could help improve your walking and physical activity. You'll also be contributing valuable information that could help others with similar conditions in the future. As with any study, there could be some minor risks, such as discomfort or tiredness from using the machine, but the team will be present to ensure your safety and comfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Alberta Children's Hospital
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is the Trexo machine?

The Trexo is a special robot-assisted device designed to help people with walking difficulties to move their legs and practice walking.

Who can take part in this study?

People with walking difficulties due to nerve or muscle conditions who can safely fit into the Trexo machine (under 5'7" and under 150 lbs).

What will I have to do in the study?

You'll have one session to get used to the Trexo, then two main testing sessions where we try different settings on the machine and measure things like your walking.

Will I have to take any medicine?

No, this study does not involve any medication. It focuses on using the robotic walking machine.

How long will I be involved in the study?

Only three visits are required (one fitting/familiarisation and two testing sessions), though you can choose to do more if you wish to explore other aspects.

How to find out more

PONI Lab

poni.lab@ucalgary.ca 4039555528 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.